A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group clinical study to Evaluate the Efficacy and Safety of Bacillus clausii PBC429™ in the Treatment of Antibiotic-associated diarrhea in Paediatricand Adult Populations.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The proportion of participants in the treatment group who achieved a Bristol
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to evaluate the efficacy and safety of Bacillus clausii PBC429™ in treating antibiotic-associated diarrhea (AAD) in pediatric and adult populations.
AAD is a common complication of antibiotic therapy, characterized by disruptions in the intestinal microbiota. It can range from mild, self-limiting episodes to severe colitis, significantly impacting patients’ quality of life and increasing healthcare burdens. Probiotics, particularly Bacillus clausii, have gained attention for their potential in preventing and managing AAD. B. clausii benefits by restoring gut microbiota balance, enhancing mucosal immunity, and inhibiting pathogenic bacteria.
The study will enroll 120 participants (60 per group), who will receive either Bacillus clausii PBC429™ (4 billion CFU/day for children, 6 billion CFU/day for adults) or a placebo for 7 days. Each participant will undergo a total treatment duration of 7 days, with an overall study participation period of 14 days. The primary objective is to assess the proportion of participants achieving normal stool consistency (Bristol Stool Scale type 3–4) within 48 hours of treatment initiation. Secondary objectives include evaluating the time to diarrhea resolution, frequency of diarrheal episodes, changes in abdominal and gastrointestinal symptoms using the Gastrointestinal Symptom Questionnaire (GSQ), and assessing tolerability and safety through adverse event monitoring and laboratory investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •To be eligible for the study, Participants must meet the following criteria:
- •Male and females aged 2 and 65 years completed years (both inclusive) with symptoms of antibiotic treatment induced diarrhea manifesting within at least 48 hours or more, at the time of screening
- •Participants with diarrhea due to ongoing antibiotic therapy (Participants should be on the initial 3-4 days of antibiotic therapy).
- •Participants have experienced at least three incidences of unformed stool (Type 6 & Type 7 by Bristol Stool form scale) within last 24 hours at the time of screening.(Annexure I).
- •Participants treated with physician’s prescribed broad-spectrum antibiotics for the last 5 days (e.g., Beta lactam, lincomycin, cephalosporin and macrolide class).
- •Willing to give written informed consent or assent form by study participants or parents wherever applicable and able to follow all study procedures.
排除标准
- •Participants with any of the following conditions will be excluded from the study:
- •Severe dehydration needing hospitalization.
- •Participants with bloody or purulent stool, with pus or mucus.
- •An axillary temperature greater than (greater than) 38.2°C or an oral temperature greater than 38.6°C
- •Symptoms of septicemia (Fever, shivering, or feeling cold, fast heart rate, fast breathing and shortness of breath, sweaty or clammy skin, etc.)
- •Unable to take medication orally or tolerate oral rehydration.
- •Taken probiotics prior to study (2 weeks) or during study other than investigational products.
- •History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.
- •Use of any laxative within 1 week before initiating study IP therapy.
- •Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP treatments.
- •History of intubations for co-morbidities (chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.
- •Use of any investigational drug currently or within 30 days prior to study entry.
- •Participant with immuno-compromised ailments such as HIV, Hepatitis B.
- •History of any psychiatric disease (including Alzheimer’s disease, Parkinson’s disease), or any other serious medical illness.
- •Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
结局指标
主要结局
The proportion of participants in the treatment group who achieved a Bristol
时间窗: Visit-1 (Day 1), Visit-2 (Day | 03±1), Visit-3(Day | 05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14)
Stool Scale type 3-4 (formed to normal stools) within 48 hours of initiation of
时间窗: Visit-1 (Day 1), Visit-2 (Day | 03±1), Visit-3(Day | 05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14)
treatment.
时间窗: Visit-1 (Day 1), Visit-2 (Day | 03±1), Visit-3(Day | 05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14)
次要结局
- Time to Resolution of Diarrhea – mean time, time taken for participants to(achieve a BSS type 3-4 stool (normal to formed stool) from the start of treatment.)
- Frequency of Diarrheal Episodes - The number of diarrheal episodes per day in(the first 48 hours post-treatment initiation.)
- Change in Abdominal Pain & other GI symptoms within 24 Hours after initiation(of treatment:)
- Tolerability of IP: To evaluate tolerability based on the frequency, severity, and(relationship of adverse events (AEs) to the study product.)
- Incidence of clinical and laboratory adverse events throughout the study period.(The following lab parameters would be evaluated at baseline and end of study)